WASHINGTON—The U.S. Food and Drug Administration (FDA) has
reopened the comment period for a proposed rule that would create standards for
direct-to-consumer TV and radio advertisements regarding drug side effects. The
rule, proposed in 2010, would require that the main point in said
advertisements be "presented in a clear, conspicuous and neutral manner." The
reopened period is intended for the assessment of a document added to the
docket, a "distraction study" to investigate factors that might influence
viewers' understanding of risks and side effects in TV advertising. The study
examined the effects of superimposed text, emotional tone of images and
consistency of images with risk information. According to the FDA's findings,
simultaneous audio and textual presentation of information improved
understanding, but no support was found that understanding is influenced by the
emotional tone of images.